What is a Software Medical Device for Interactive system for ordering medication
Is Your Software a Medical Device for Interactive system for ordering medication
1. Technical Field
The present invention relates to a medication ordering system and more specifically to an system that is dynamic and flexible, and is designed for rapid medication and prescription order entry and which has been integrated into the system is a source and communication network, providing users with drug, patient, and prescribing information.
2. Discussion
Essential in medicine practice is the prescribing and ordering of drugs. The physician must have an abundance of information about the patient, such as their medical history and understanding of pharmacology and drugs. They also need to be able to draw upon clinical and therapeutic data. The decision of the doctor to prescribe drugs the doctor has a major effect on the treatment and cost.
Typically, doctors order medications through writing an order into the chart of hospitalized patients or by writing a drug prescription on a prescription blank for patients who are not hospitalized. The doctor typically relies on personal knowledge supplemented by readily available references (e.g., journals, books or professional consultations, etc.) as well as a deep understanding of the patient’s medical condition when forming a therapeutic medication regimen.
Computer systems are currently showing promise in improving the process of prescribing and ordering drugs. For example, a drug prescription or order could be entered directly into a computer and sent electronically, thereby shortening the time between when the prescription is completed until it arrives at the pharmacy. A lot of systems focus on order entry.
There are two kinds of hospital pharmacy computers systems. The first is a “stand-alone” system. It is an independent computer for pharmacy system that regulates all of the operational tasks such as medication dispensing, billing,inventory, etc. Typically, two separate hospital departments interface with the “stand-alone” system. One department is responsible for patient admissions, transfers and discharges (ADT), while the other accepts billing and financial transactions.
The other type of computerized pharmacy system, the “total hospital system” is functionally identical to the “stand-alone” system but has been incorporated into a computer network that interconnects every department of the hospital. Each department(e.g., laboratory or radiology, pharmacy, medical records) is accessible via computers located throughout the hospital.
With “stand-alone” systems medication order processing begins with transmission of faxed or printed orders to the pharmacy. There are inefficiencies such as unnecessary paperwork, and duplicate processes during the delivery and handling process. Technicians or pharmacists enter orders into computers. Troubles with medication orders may take a while to resolve due to the time between when the order was written and received by the pharmacy.
In order to improve the efficiency of the ordering process “Total Hospital Systems” transfer the responsibility of entering orders into the computer to the prescriber (i.e. physicians). These orders might include lab tests, medication diets, tests, etc. In these systems, the doctor makes the orders directly on computers. The result is a reduction in paperwork and task duplication. However, many challenges remain. Computer order entryinefficiencies exist due to the slow and complicated routes for ordering medications. As an example, it’s customary for pharmacy programs in “total hospital” systems as in “stand-alone” systems to have strict ordering pathways that require a number of steps to complete basic tasks.
They are standardized entry format, which requires prescribers to take certain steps when entering medication orders. Separate orders need to be made for different ways of administration. For instance, an order for “Phenergan 25 mg PO/IM, q6h prn” would require two separate order entries one to select the oral (PO) tablet, and another for choosing the intramuscularly injection (IM)preparation. Additionally, more complicated orders (e.g. corticosteroid tapers) require extensive entry steps by the doctor.
In addition, the automated order entry systems used for prescriptions don’t address other issues. For example, relevant patient medication information is often not readily available to the prescriber in a complete,comprehensive and organized format. This information includes a list of all medications, both past and present, as well such as weight, height and age. Additionally, it provides details about allergies to drugs as well as adverse reactions. This information is crucial in making decisions about medication. In addition, current systems do not keep the prescriber informed about the formulation of drugs and their availability, as well as of the guidelines for hospital prescribing and restrictions. For instance, information on prescribing in relation to clinical practice guidelines, Medicaid restrictions, multi-disciplinary action plans (MAP’s) and clinical practice standards or clinical pathways all need to be communicated to the prescriber in an effective manner. The other shortcomings of current systems are the need for help in the calculation of doses for drugs using pharmacokinetic data, and the need for providing the prescriber with current laboratory data pertinent to the use and dosage of specific medications.
Because of these weaknesses in existing pharmacy computer systems, it is ideal to have a computerized prescription order entry system that can overcome the inefficiencies and weaknesses. It is ideal for the system to be more adaptable and user-friendly. It is ideal for the system to be able to mimic the current and traditional ways of prescriptions and adapt computerized pathways to manage the orders. In addition, it would be beneficial to offer a system that makesavailable to the doctor a range of data about the patient’s history of medication and interactions with drugs, allergies as well as recommended doses. To avoid unintended consequences, this system would inform the prescriber of any interactions with drugs and negative reactions to drugs. The system will communicate with prescribers in order to apply prescribed guidelines and restrictions, as well as inform them of the cost of drugs. This system will also help the prescriber in making the right dosage and drug selections in light of patient information, pharmacokinetic evaluations as well as laboratory findings.
The invention provides the method and system of prescribing medications to patients. Interactive software is utilized to assist the prescriber in identifying the patient. The prescriber is able to interact with the system in a variety of ways, including either a mouse or keyboard pen-based entry or even voice entry. The system contains a database that includes medical prescribing information and information about drugs. This data can be general (e.g. dosage recommendations and pharmacology) and restrictions) or specific to the patient (e.g. allergies and adverse drug reactions, medication history). The system also includes an application for accessing the database and showing the doctor a list of active and inactive medicationsfor the patient. The system accepts and processes prescriptions and medications for the patient from the prescriber which are typically comprised of dosage, drug the medication is administered, the route of administration and frequency. In addition, the system communicatesthe medication order to the hospital pharmacy or the prescription to the outpatient/clinic/retail pharmacy. The preferred embodiment will take prescriptions or orders for medication in random order and interpret and reformat them for processing.
In accordance with one feature of the invention described hereinafter, the invention provides a method that aids in selecting a person and then obtaining all relevant health and medication information for the patient. The system also alerts the prescriber to potential adverse events that could result from an order or prescription medication based on existing information on the patient stored in the database. The system could notify the prescriber of a possible allergic reaction or drug interaction if amedication has been ordered.
According to an additional aspect of the invention the system will automatically choose the appropriate product according to the descriptions (e.g. drug, dose frequency, the route of administration) and allows for communication of the prescription or order with the pharmacy. The system has an interface to create and store data pertaining to predetermined circumstances such as ordering prescription drugs that are not on the form prescription restrictions for certain drugs, not recognized or unobtainable dosage entries that are questionable possible drug interactions and predetermined order sets. The system will automatically display the user with a specific configuration message the user whenever a medication order or prescription represents the event of one of these predetermined scenarios. These pre-determined situations can be defined and messages generated using an interface. The interface permits users to create pre-determined orders which will be triggered when certain mnemonic codes are entered.
A process is provided that allows drug users to assess the effects of their drugs and their dosage using the available data from pharmacokinetics and laboratory tests.
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What is a software medical device?
The FDA could refer to functions in software, which include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)” that are programs that are integral (embedded inside) a medical device.
Section 201(h) of the?Federal Food Drug and Cosmetic Act, 21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, instrument machines, devices, implant in vitro regulators, or any other similar or similar items and a component or accessory. . . (b) is intended to be used to diagnose diseases or other conditions, or for the treatment or mitigation of disease, or prevention of disease, for animals or humans, or (c) intended to affect the structure or the function of the body of man or any animal.? To be considered a medical device, and consequently subject to FDA regulations, the software must meet at least one of these requirements:
- It should be designed to be used in diagnosing or treating a patient; or
- It is not intended to alter the structure or function of the body.
If the software you use is designed to be used by healthcare professionals to diagnose, treat, or manage hospital patient records, the FDA will likely consider such software as medical devices subject to regulatory review.
Is Your Software a Medical Device?
FDA’s current oversight, which focuses on the features of the platform rather than the actual software, will allow FDA to regulate medical devices that could pose danger for patient safety. Some examples of Device Software and Mobile Medical Apps FDA is focused on
- Software functions to aid those suffering from mental illness (e.g., anxiety, depression and post-traumatic stress disorder (PTSD), etc.) through the use of “Skill of the Day”, a behavioral technique or audio-based messages that the user is able to access when suffering from anxiety.
- Software functions provide regular educational information, reminders, or motivational tips for smokers who are trying to quit, patients who are recovering from addiction or pregnancies women;
- Software functions that use GPS location information to notify asthmatics when they are near areas of high risk (substance users) or inform them of possible environmental conditions that could cause symptoms.
- Software that makes use of video and games to encourage people to do their take part in exercise at home.
- Software functions allow users to select which medication or herb they would like to take at the same time. They also provide information on interactions and provide an overview of the type of interaction reported.
- Software functions that utilize the characteristics of the patient like age, sex and risk factors for behavioral health to offer specific screening for patients, counseling and preventive recommendations from well-known and established authorities;
- Software functions that make use of a list of typical symptoms and signs to give an overview of health conditions and advise on when it is appropriate to speak with a health care provider;
- Software functions that guide users through a list of signs and symptoms to give a recommendation on the health care facility most appropriate to their needs;
- The mobile apps enable users to make nurse calls, or emergency calls using broadband or cell phone technology.
- Apps that allow patients or caregivers to communicate emergency alerts to first responders using mobile phones
- Software functions that track the use of medications and provide user-configured reminders for improved medication adherence;
- Software functions that provide patients with a way to access their own health data, such as access to data gathered during a prior visit to a doctor or historical trends and comparison of vital indicators (e.g. body temperature and heart rate, blood pressure, or respiratory rate);
- Software functions that show trends in personal healthcare incidents (e.g. rate of hospitalization or alert notification rate)
- Software functions that allow a user to collect (electronically or manually input) blood pressure data , and transmit this data via email, track and trend it, or upload it to an electronic or personal health record;
- Mobile apps that provide oral health reminders or tracking tools for those suffering from gum disease.
- Mobile apps offer patients suffering from prediabetes with advice or tools that can help them develop better eating habits or increase physical activity
- Apps that let users display messages and images on mobile devices that can be utilized by substance abusers who want to stop their addiction.
- Software functions that report drug-drug interactions and relevant safety information (side effects, interactions between drugs and active ingredient) as a report based on demographics (age, gender) and clinical information (current diagnosis), and current medications and
- Software functions that allow the surgeon to determine the best intraocular lens powers for the patient, as well as the direction of the implantation. This information is based on surgeon’s inputs (e.g. anticipated surgically induced astigmatism and length of the patient’s axial axis, preoperative corneal astigmatism etc.).
- Software, usually mobile apps, converts a mobile platform into a medical device that is regulated.
- Software that is connected to a mobile platform using a sensor or a lead to measure and display the electrical signals generated by the heart (electrocardiograph, ECG).
- Software that connects sensors to the mobile platform or other tools in the platform, in order to monitor the eye movements, record and analyze the eye movements to identify balance issues
- Software that inquires about their history with donors and their records, and transmits those answers to a blood collection facility. The software will determine whether a person is eligible to donate blood or other components.
- Software that connects with an existing device type to control its operation function or energy source.
- Software that alters or deactivates the functions of an infusion pumps
- Software that regulates the inflation or deflation of the blood pressure cuff
- Software that is used to calibrate hearing aids and to evaluate the electroacoustic frequency, sound intensity characteristics, and coming from hearing aids, master hearing aids, group hearing aids, or group auditory trainers.
What does it mean if your software/SaaS is classified as a medical device?
SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.
So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.
Software As Medical Device Patenting Considerations
The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.
Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.
In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.
The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.
When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.
An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.
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